Could another Guatemala case happen?

At the Presidential Commission for the Study of Bioethical Issues today, Commission Chair Dr. Amy Gutmann, president of the University of Pennsylvania, asked a panel of international experts on bioethics whether the so-called Guatemala incident could happen again. In Guatemala, from 1946 to 1948, a U.S.-funded research experiment deliberately infected people in a trial with sexually transmitted diseases and in some cases did not treat them.

“Of the many things that happened there, no, it could not happen again because of informed consent,” said Dafna Feinholz, chief of the Bioethics Section, Division of Ethics and Science and Technology, Sector for Social and Human Sciences, United Nations Educational, Scientific and Cultural Organization.

But she said there was great room for improvement in the current sets of regulations guiding clinical trials. She specifically mentioned the area of “how to enter negotiations about research projects, about what is relevant, and why is it being conducted.”

Others on the panel agreed that human subjects in clinical trials remained vulnerable today.

Francis P. Crawley, executive director of the Good Clinical Practice Alliance in Europe, championed the need for more transparency around clinical trials. First, he thanked the panel and Susan Reverby, the Wellesley College professor whose research uncovered the Guatemala experiments last year, leading President Obama to ask the Commission to investigate that study as well as whether federal funded research adequately protected human subjects in trials.

“I think this work by Dr. Reverby was done in an exemplary way as a historian, ethicist, and a human being,” Crawley said. “One of the things Dr. Reverby has done is to bring something out of darkness. And that is really, really important to us.”

He continued: “We need to consider carefully what we do as ethicists. Are we protecting human subjects? Is that what we are about? Are we justifying research of subjects? Are we advancing health? How are we advancing health? What are our roles and what should be our principle objective here? I think our primary objective should be health.”

Crawley said now there was a “trust deficit” between researchers and possible subjects of trials. He said that the U.S government, European governments and the World Health Organization have all moved quickly to promote more transparency of the clinical research.

But Commission member Anita L. Allen, professor of law and philosophy at the University of Pennsylvania, questioned whether transparency was the main problem.

“It’s often said that African Americans’ distrust of clinical medicine is due to a belief if a group is low enough in social status, (abuses) can happen in broad daylight,” she said. “Slavery and the Holocaust happened in broad daylight. So is transparency the key? Or is human rights and equality really the key?”

“I agree with you entirely,” Crawley said. “ … Trust is really the key issue here. It’s very important we maintain trust in research. … Transparency is in and of itself insufficient. It will never be sufficient. It is a necessary condition, but it is not sufficient.”

Commission member Christine Grady, deputy chief of the Department of Bioethics at the National Institutes of Health Clinical Center, raised another thorny issue: Do the interests of people participating in a clinical trial trump everything else?

Gutmann asked Grady to answer her own question.

“Sometimes the interest, the immediate interest, especially the medical interest of the individual at hand are not the primary focus of what is going on,” Grady said. “… The sort of struggle that has occupied many people for many years is what level of risk do we allow people to take if they are able to make autonomous decisions in the interest of science, in the interest of developing new knowledge that will help other people. That is really a very tough question.”

Johannes J.M. van Delden, president of the Council for International Organizations of Medical Sciences, said that in many cases “clinical research cannot be beneficial for the participants. … Usually there will be procedures that are harmful, or certainly not beneficial.”

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This is a space for the members and staff of the Presidential Commission for the Study of Bioethical Issues to communicate with the public about the work of the commission and to discuss important issues in bioethics.